ADVERSE REACTIONS

Clinical Studies Experience sections re-named

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Fetal Toxicity [see Warnings and Precautions].

Anaphylactic Reactions and Head and Neck Angioedema [see Warnings and Precautions].

Hypotension [see Warnings and Precautions].

Postmarketing Experience

Aliskiren: nausea, vomiting added

DRUG INTERACTIONS

Aliskiren

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS)

added...Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min.

added...The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated [see Contraindications (4)].